Halo® TE

A Standardized and Validated Bioluminescence Assay to Predict Neutrophil, Platelet and/or Erythroid Engraftment

Description	Species & Tissue	Formulation	Catalog Number	Quantity
Lineage-Specific Cells
P-BFU 1	Bone marrow or peripheral blood	Low serum	K2-BTE-1	1 Kit
P-GM 1	Bone marrow or peripheral blood	Low serum	K2-GMTE-1	1 Kit
P-Mk 1	Bone marrow or peripheral blood	Low serum	K2-MkTE-1	1 Kit
P-BFU1 + P-GM 1 + P-Mk 1	Bone marrow or peripheral blood	Low serum	K2-3PTE-3	1 Kit
Lineage-Specific Cells
B-BFU 1	Bone marrow or peripheral blood	Serum-Free	K2SF-BTE-1	1 Kit
P-GM 1	Bone marrow or peripheral blood	Serum-Free	K2SF-GMTE-1	1 Kit
P-Mk 1	Bone marrow or peripheral blood	Serum-Free	K2SF-MkTE-1	1 Kit
P-BFU 1 + P-GM 1 + P-Mk 1	Bone marrow or peripheral blood	Serum-Free	K2SF-3PTE-3	1 Kit

• No need to wait for >500 neutrophils/µL and 50,000 platelets/µL of blood after transplantation. HALO® TE can predict the production of neutrophils, platelets and/or red blood cells.
• No 14 day cultures. Just a short 5 day incubation that can predict engraftment.
• Perform multiple time prior to actual engraftment. Especially important for cord blood, which requires longer to engraft than bone marrow or mobilized peripheral blood.
• No tedious colony counting required. Cell proliferation data provides rapid, efficient and reliable information. 
• Suspension Expansion Culture™ (SEC™) Technology allows high accuracy and precision and rapid dispensing of reagents making the use of methylcellulose obsolete.
• Incorporates ATP Bioluminescence Technology, the most sensitive and accurate readout available.
• Fully standardized, verified and validated readout according to FDA guidelines.
• Proficiency testing performed and completed during assay standardization procedure. No additional costly and time-consuming proficiency testing required.
• Measurement assurance parameters provide proficiency and trust in your results.
• Correlates with CFU assay; multiplexes with flow cytometry and other readouts.
• 96-well plate format ensures smaller sample and reagent volumes with faster setup.
• Let the plate reader acquire and calculate results in just 5 minutes or less.
• Directly compare potential engraftment of different donor tissues in patients to provide qualified historical data over time.
• Includes everything needed to culture and measure lineage-specific or tri-lineage engraftment. Just prepare and add cells.
• Time-efficient and highly cost-effective.
• Easy to learn in just 1 day.

All ATP bioluminescence assays kits from Preferred Cell Systems™ include an ATP standard(s) and controls.  Performing the ATP standard curve and controls is highly recommended. The controls are used to calibrate the luminescence plate reader and the ATP standard is used to standardize the assay. The values obtained from the standard curve and controls (see diagram below) are then compared to the measurement assurance parameters that are provided in the instruction manual. If the values obtained are within the ranges provided by the measurement assurance parameters, you, the user, have successfully performed the proficiency testing to ensure that you have not only performed the assay correctly, but that the results you obtain can be trusted.

No additional proficiency testing is required if the calibration and standardization procedure is performed. The values you obtain from each calibration and standardization can be logged and used for certification that the assay has been performed correctly and that the results are trustworthy.


 

The following assays are available to monitor Time to Engraftment:

• P-BFU 1 for erythroid engraftment.
• P-GM 1 for neutrophil engraftment
• P-Mk 1 for platelet engraftment
• P-BFU 1 + P-GM 1 + P Mk 1 for multilineage engraftment

Each assay can monitor a maximum of 24 samples at 4 replicates each. Higher numbers of replicates can also be used.

• Umbilical cord blood
• Peripheral blood
• Bone marrow biopsy

Tissues Used for Detection

• Peripheral blood
• Bone marrow biopsy

The recommended cell purity is a mononuclear cell (MNC) fraction. A total nucleated cell (TNC) fraction is not recommended as this contains high concentrations of cell impurities, such as red blood cells, neutrophils, platelets and other cells that severely underestimate and even inhibit the detection of progenitor cells. 

For Research Use Only. Not for clinical diagnostic use.

Luminescence or multimode plate reader with "glow" luminescence measuring capability.

• HALO® PT Master Mix (Low serum or serum-free formulations)
• ATP standard
• ATP high and low controls
• ATP Enumeration Reagent
• Sterile, 96-well plates
• Non-sterile, 96-well plates
• Sterile, adhesive foil covers

A specific video tutorial on using the TE assays is not yet ready. Please scroll down and check out the QuickGuide and Technical Manual (if available). Below, are the links to perform the ATP bioluminescence, fluorescence or absorbance readout:

How to Calibrate and Standardize an ATP Bioluminescence Assay - Part 1 (for HALO® TE)

How to Calibrate and Standardize an ATP Bioluminescence Assay - Part 2 (for HALO® TE)

Proficiency Testing for Hematopoietic Cellular Therapy Products
 

 

Download the HALO® TE Technical Manual
Download the ATP Optimization Kit Protocol for First-Time Users
Download Luminometer Setup and RLU to ATP Conversion
Download Certificate of Analysis (CoAs) for ATP Enumeration Reagent (ATP-ER)
Download Certificate of Analysis for ATP Stanadrds
Download Certificate of Analysis for ATP Controls
Download Certificate of Analysis of ATP Reconstitution Reagent
Download Certificate of Analysis for Sterile 96-Well Plates
Download Certificate of Analysis for Non-Sterile, 96-Well Plates
Download Certificate of Analysis for Sealing Films
Download Certificate of Analysis for IMDM